Fractyl Health, Inc. filings document regulatory, financial, governance and capital-structure disclosures for a clinical-stage metabolic therapeutics company developing Revita® and the Rejuva® gene therapy platform. Form 8-K reports furnish operating results, corporate presentations, REMAIN-1 clinical updates, Revita regulatory communications, Rejuva clinical-trial authorization for RJVA-001, and other Regulation FD disclosures.
The filing record also includes proxy materials for annual-meeting governance and equity-compensation matters, common stock and warrant disclosures, including Tranche A Common Stock Purchase Warrants, and Nasdaq continued-listing compliance notices. These documents describe the company’s public-company reporting, capital structure, stockholder voting matters and development-stage corporate disclosures.
Fractyl Health, Inc. (GUTS) is concentrating resources on Revita and discontinuing internal development of its Rejuva gene therapy program while seeking strategic alternatives. It plans a workforce reduction of approximately 45%, expected to be completed in the fourth quarter of 2026; estimated severance and other termination-related costs are approximately $2 million, with most expected in that quarter. The cost estimate and timing are subject to assumptions, and actual results may differ.
Fractyl expects existing cash and cash equivalents to fund operations into Q2 2027 and quarterly operating cash burn to be reduced approximately 50% to approximately $8 million by the end of Q2 2027. Six-month REMAIN-1 pivotal results met the prespecified co-primary endpoint for weight regain versus sham with high statistical significance (p=0.0023). The company plans a Revita FDA De Novo marketing application submission in late Q4 2026 and anticipates 12-month pivotal data in Q1 2027. Jay Caplan, Co-Founder, President and Chief Product Officer, retires from executive roles effective October 30, 2026, and is expected to support the company as a senior advisor. Harith Rajagopalan, Co-Founder, CEO and director, becomes President that day.
Fractyl Health, Inc. (GUTS) reported that Revita met the six-month co-primary endpoint in the ongoing REMAIN-1 Pivotal Cohort: in the modified intention-to-treat (mITT) population, least-squares mean weight regain was 5.1% with Revita versus 8.2% with sham (n=176 vs. 74; p=0.0023). Participants retained approximately 80% of GLP-1-induced weight loss with Revita versus 67% with sham. A post hoc analysis found 32% of Revita participants were weight stable or had further weight loss, compared with 18% on sham.
In post hoc analyses by treatment length, mean weight regain was 4.7% after 12–18 cm of duodenal ablation and 3.8% after 20 cm or more, compared with 8.2% for sham. The study remains ongoing; its second co-primary endpoint assesses the share of Revita participants maintaining at least 5% total body weight loss at 12 months, with topline data expected in Q1 2027. As of September 24, 2026, there were no device- or procedure-related serious adverse events, deaths, or unanticipated adverse device effects; 94% of related adverse events occurred within seven days. A potential De Novo marketing application submission is planned for late Q4 2026, and Category III CPT code 1122T takes effect January 1, 2027. Revita remains investigational for use in the United States.
Fractyl Health, Inc. had 736,807 common shares reported as beneficially owned by Catalio Capital Management, LP, equal to 5.55% of the class as of September 30, 2026. The same beneficial-ownership position is also listed for Catalio Capital GP, LLC, R Jacob Vogelstein, and George Petrocheilos. Catalio says it has sole voting and dispositive power over the securities; Vogelstein and Petrocheilos are identified as sole members of its general partner with voting and dispositive power. Catalio managed shares held by Catalio Public Equities Fund, LP, Catalio Nexus Fund II, LP, and separately managed accounts.
Fractyl Health, Inc. (GUTS) will combine every 12 issued and outstanding common shares into one share in a 1-for-12 reverse stock split, effective at 5:00 p.m. Eastern Time on October 2, 2026. The common stock will begin trading on a split-adjusted basis when the market opens on October 5, 2026.
Outstanding stock options, restricted stock unit awards, warrants and shares reserved under equity compensation plans will be proportionately adjusted. No fractional shares will be issued; stockholders of record otherwise entitled to a fractional share will receive cash in lieu. The split will affect stockholders proportionately and will not change their percentage ownership, except where a stockholder would own only a fractional share.
Fractyl Health, Inc. (GUTS) reports that stockholders approved alternate amendments authorizing the board, at its option, to effect a reverse stock split at a ratio from 1-for-5 to 1-for-15, inclusive. The board has sole discretion to determine the ratio. At the September 24, 2026 special meeting, 102,476,581 votes were for the proposal, 9,319,450 were against and 191,821 were abstentions.
Of 159,179,848 common shares outstanding as of August 21, 2026, 111,987,852 shares were represented at the meeting, approximately 70.35% in voting power of the common stock outstanding and entitled to vote.
FRACTYL HEALTH, INC. (GUTS) director William Bradley reported an open market purchase of common stock. On September 14, 2026, he bought 64,516 shares of common stock at $0.6185 per share. Following this transaction, he directly holds 149,138 shares of FRACTYL HEALTH common stock, and no Rule 10b5-1 plan is reported.
Fractyl Health, Inc. (GUTS) reports that Nasdaq has notified the company its common stock is subject to delisting from the Nasdaq Global Market because it did not regain compliance with the $1.00 minimum bid price requirement within the 180-day grace period that ended September 9, 2026. The company plans to timely request a hearing before a Nasdaq Hearings Panel, which will automatically stay any suspension or delisting while the hearings process is pending, so the stock is expected to continue trading on Nasdaq during that time. Fractyl has already filed a proxy statement seeking shareholder approval for a reverse stock split at a ratio between 1-for-5 and 1-for-15 as a potential way to restore compliance by achieving a closing bid of at least $1.00 per share for the required 10 to 20 consecutive business days.
Fractyl Health, Inc. (GUTS) is calling a virtual special stockholder meeting on September 24, 2026 at 12:00 p.m. Eastern to vote on a single proposal authorizing its Board to implement a reverse stock split of the common stock at any ratio between 1‑for‑5 and 1‑for‑15, at the Board’s discretion, within 12 months.
There were 159,179,848 shares of common stock outstanding and entitled to vote as of the August 21, 2026 record date. The company states the reverse split is intended primarily to raise the per‑share trading price to help regain and maintain compliance with Nasdaq’s $1.00 Minimum Bid Price Requirement after receiving a deficiency notice in March 2026. The split would reduce shares outstanding but leave the authorized common stock at 300,000,000, increasing the number of authorized but unissued shares.
The reverse split would proportionally adjust outstanding options, RSUs and warrants (fewer shares, higher exercise prices) and aggregate fractional interests into cash payments based on the average closing price over the five trading days before effectiveness. Ownership percentages and voting power per holder are expected to remain essentially unchanged, aside from holders whose positions are entirely cashed out due to fractional shares.
Fractyl Health, Inc. is calling a virtual special stockholder meeting on September 24, 2026 to vote on a single proposal: approval of a reverse stock split of its common stock at a ratio between 1‑for‑5 and 1‑for‑15, at the Board’s discretion. As of June 30, 2026, Fractyl had 158,648,963 common shares outstanding and authorization for 300,000,000 shares in total.
The Board states the main reason is to help regain compliance with Nasdaq’s $1.00 Minimum Bid Price Requirement. Fractyl received a Nasdaq deficiency notice on March 13, 2026 after its stock traded below $1.00 for 30 consecutive business days and has until September 9, 2026 to cure, but has not yet done so and does not expect to qualify for transfer to the Nasdaq Capital Market. A reverse split would reduce outstanding shares (for example to 15,864,896 at a 1‑for‑10 ratio) but leave the 300,000,000 authorized share count unchanged, increasing the pool of unissued shares available for future use.
The reverse split would proportionally adjust outstanding equity awards, including 19,389,492 options at a weighted average exercise price of $3.60, and no fractional shares would be issued; instead, holders would receive cash based on the average closing price over five days. The company describes the transaction as a tax‑free recapitalization for most U.S. stockholders, with cash in lieu of fractional shares generally taxed as a capital gain or loss.
Fractyl Health, Inc. reported a Q2 2026 net loss of $25.5 million and a six‑month 2026 net loss of $16.3 million, with no product revenue as it remains a clinical‑stage company. Operating expenses were driven by $13.8 million of research and development and $5.3 million of selling, general and administrative costs in the quarter.
For the six months, research and development spending was $29.4 million, down from the prior year period due to lower Revita and Rejuva program costs and reduced headcount. Other income reflected a $24.6 million non‑cash gain from the change in fair value of warrant liabilities, partly offset by losses on notes payable.
Cash and cash equivalents were $47.1 million as of June 30, 2026, with net cash used in operating activities of $38.4 million in the first half. Management expects existing cash to fund operations into early 2027 but concluded there is substantial doubt about the company’s ability to continue as a going concern for at least 12 months from issuance without additional financing or cost reductions.
Clinically, Fractyl reported encouraging weight‑maintenance data from its Revita REMAIN‑1 program and advanced its Rejuva gene therapy platform, including CTA authorization in the Netherlands and ethics approval in Australia for lead candidate RJVA‑001.